Valena Cream

Indications

Valena Vaginal Cream 0.01% is recommended for managing moderate to severe symptoms associated with vulvar and vaginal atrophy resulting from menopause.
Always follow the advice of a registered healthcare professional before using this medication.

Pharmacology

The development and maintenance of the female reproductive system and secondary sexual characteristics are primarily influenced by endogenous estrogens. Among these, estradiol serves as the dominant intracellular human estrogen, exhibiting significantly higher potency at receptor sites compared to its metabolites, estrone and estriol. This dynamic equilibrium of circulating estrogens involves various metabolic interconversions.

Dosage

The typical dosage is between 2 to 4 grams (as indicated on the applicator) per day for one to two weeks, followed by a gradual reduction to half the initial dosage for an equal duration. Once the vaginal mucosa is restored, a maintenance dosage of 1 gram, administered one to three times weekly, may be appropriate.
Always consult with a registered healthcare professional regarding medication usage.

Administration Instructions

1. Thoroughly wash your hands with soap and water.
2. Carefully open the sealed wrapper and extract the applicator.
3. Insert the applicator tip into the cream tube.
4. Press down on the tube to dispense the prescribed amount of gel (2g – 4g as marked) into the applicator.
5. Remove the applicator from the tube.
6. Gently insert the applicator’s rounded tip into the vagina.
7. Push the plunger to administer the gel.
8. After application, remove the applicator and clean it for future use.
   Always seek guidance from a registered healthcare professional regarding the use of this medication.

Interactions

Medications such as phenobarbital, carbamazepine, and rifampin may lower plasma estrogen levels, potentially diminishing therapeutic effects and altering uterine bleeding patterns. Conversely, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice can increase estrogen concentrations in the bloodstream, possibly leading to side effects.

Contraindications

Valena Vaginal Cream should not be used by women who have any of the following conditions:

• Undiagnosed abnormal genital bleeding.
• Known or suspected breast cancer.
• History of estrogen-dependent tumors.
• Current or past deep vein thrombosis or pulmonary embolism.
• Recent arterial thromboembolic events (e.g., stroke, myocardial infarction).
• Liver dysfunction or disease.
• Known hypersensitivity to any ingredients in the cream.
• Suspected pregnancy, as there is no indication for use during this time. Research indicates minimal risk of birth defects in children whose mothers inadvertently used estrogens and progestins from oral contraceptives during early pregnancy.

Side Effects

Possible side effects include headache, breast discomfort, irregular vaginal bleeding or spotting, abdominal cramps, bloating, nausea, vomiting, hair loss, fluid retention, and vaginal yeast infections. Local reactions such as vaginal burning, irritation, or itching may also occur upon application of Valena Vaginal Cream.

Pregnancy & Lactation

Valena should not be used during pregnancy. While research indicates little to no increased risk of birth defects in children born to women who used estrogens and progestins inadvertently during early pregnancy, caution is still advised.

Precautions & Warnings

Patients using additional progestins alongside Valena may face an increased risk of endometrial hyperplasia, which is a precursor to endometrial cancer. Other potential risks include elevated blood pressure and hypertriglyceridemia, especially in those with a history of high triglyceride levels. Caution is advised for individuals with hepatic impairment, a history of cholestatic jaundice, hypothyroidism, or hypocalcemia. Estrogen can worsen conditions such as endometriosis, asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Therefore, Valena Vaginal Cream should be used cautiously in women with these pre-existing conditions.

Overdose Effects

Excessive estrogen intake may lead to symptoms such as nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Withdrawal bleeding may occur in women. In case of an overdose, discontinue Valena therapy and provide appropriate symptomatic care.

Storage Conditions

Store Valena Vaginal Cream at temperatures not exceeding 30°C. Keep it away from light and out of reach of children.